|Publication number||US5141518 A|
|Application number||US 07/664,652|
|Publication date||25 Aug 1992|
|Filing date||5 Mar 1991|
|Priority date||5 Mar 1991|
|Also published as||WO1992015360A1|
|Publication number||07664652, 664652, US 5141518 A, US 5141518A, US-A-5141518, US5141518 A, US5141518A|
|Inventors||Robert L. Hess, Jeffrey P. Callister|
|Original Assignee||Progressive Angioplasty Systems, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (17), Referenced by (50), Classifications (10), Legal Events (9)|
|External Links: USPTO, USPTO Assignment, Espacenet|
1. Field of the Invention
The present invention relates to balloon angioplasty catheters and particularly to catheters which provide an inflation tube and a guidewire for pushability and steerability purposes.
2. Description of the Prior Art
There currently are two basic types of balloon angioplasty catheters--"over the wire" ("OTW") and "fixed wire" ("FW").
An OTW catheter provides a tube to accept a guidewire which is moveable and removable and can be extended distal to the distal end of the catheter for steering purposes. An inflation tube is also provided. The advantages of such a catheter are its steerability, column strength (pushability) and the possibility of exchange using the wire. The disadvantage is primarily the catheter's large profile since the device requires two tubes, one concentrically positioned inside the other, to provide an annular passage therebetween for passage of inflation fluid. The wire in such a catheter passes within the inner tube. Unfortunately, the number of components and the annular space increases the overall diameter (profile) of the device and limits its utility.
FW catheters have a single inflation tube around a fixed wire which allows a lower profile. However, this feature is gained at the expense of steerability, pushability and the ability to exchange the wire. Although FW catheters require only one tube and can therefore be smaller in cross-sectional diameter than an OTW catheter, the FW catheter requires space between the inside of the tube and the outside of the fixed wire for the passage of inflation fluid. The larger the diameter of the wire, the larger the diameter of the catheter --thereby limiting the utility of the catheter and also affecting its tractability. FW catheters are also limited because the physical characteristics of the wire, i.e., flexibility, diameter, and taper must be predetermined, thus compromising the FW device's ability to either cross a lesion or to steer the wire with a floppy tip that may be attached to the catheter. In such a situation, the FW catheter must be removed and replaced by another FW catheter, thereby causing further trauma to the blood vessel. These limitations were recognized in U.S. Pat. No. 4,932,959 to Horzewski et al. wherein a catheter is provided with a central tube which slidably receives a guidewire which can be moved back and forth to vary the flexibility of the distal end of the catheter. Unfortunately, in such a device the guidewire is a permanent part of the catheter, and a passage between the wire and the tube must be provided, thereby increasing the overall diameter of the catheter.
As seen from the above discussion, it would be desirable to have a balloon angioplasty catheter having a smaller overall diameter than an FW catheter, yet retaining the variable pushability and steerability of an OTW catheter.
The purpose of the invention is to provide a balloon angioplasty catheter having the smallest cross-sectional diameter profile possible while providing steerability and pushability. To accomplish this purpose there is provided a catheter which can simply be described as a "balloon on a tube." The instant invention has a tube with a balloon connected to the distal end thereof which accepts a wire, the space between the wire and the tube being sufficient to insert and rotate the wire in the tube yet being insufficient around the inserted wire to allow inflation or deflation of the balloon. The distal tip of the wire is provided with means for engaging and detaching from a rotatable floppy tip assembly to allow steerage of the catheter. The combination of the wire and tube provides exceptional pushability accommodating the insertion of different strength wires wherein stiffness can be varied. The guidewire of the invention is removed during the inflation or deflation of the balloon.
In one aspect of the invention there is provided an angioplasty catheter comprising: a tube, said lumen being elongated and having a proximal end and a distal end; a balloon-like member connected to said lumen at the distal end thereof; and a guidewire removably insertable within said lumen in close-fitting relationship thereto sufficient to allow axial and rotatable movement of the guidewire therein but insufficient to allow adequate inflation or deflation of said balloon.
FIG. 1 is an exploded perspective view of the catheter of the invention including a partially sectioned catheter body and a representative guidewire. FIG. 1A shows the end of another guidewire that can be alternatively inserted into the catheter body.
FIG. 2 is a cross-sectional view of the catheter body with the guidewire inserted therein taken along cross-sectional line 2--2 in FIG. 1.
FIG. 3 is a cross-sectional view similar to FIG. 2 of a prior art fixed wire catheter with a permanent guidewire surrounded by a tube and having an annular space therebetween for passage of balloon inflation fluid.
FIG. 4 is a cross-sectional view similar to FIG. 2 of a prior art over the wire catheter having concentric tubes and a guidewire positioned within the innermost tube. Space is provided between the tubes for passage of balloon inflation fluid.
FIG. 5 is a partial cross-sectional view of the catheter of the subject invention. One of the guidewires has been inserted within the catheter body, and the distal tip of the guidewire has engaged the rotatable floppy tip assembly to steer the catheter.
FIG. 6 is a partial perspective view similar to FIG. 5 wherein the guidewire has been removed and the balloon portion of the catheter has been inflated through the catheter body.
With continued reference to the drawing, FIG. 1 illustrates an exploded perspective view of the angioplasty catheter 10 of the invention. Catheter 10 includes tube 12, having balloon-like member 14 connected thereto, and guidewire 16 which is removably insertable within tube 12. Tube 12 has a proximal end 18 and a distal end 20. Balloon-like member 14 is connected at distal end 20. A Y-adaptor, or the like, can be attached to proximal end 18 of tube 12 for insertion and removal of guidewire 16 and to allow access to the inside of tube 12 for purposes of inflating balloon-like member 14 once guidewire 16 is removed.
Tube 12 is preferably a wire wound member that is coated to seal the tube for passage of a fluid therein. It is within the scope of the invention to have tube 12 be made of a polymeric material, a coated braid, or other like flexible, sealed conduit. One example is a wire wound member constructed of 0.002 inch by 0.008 inch helically wound Type 304 stainless steel wire coated with 0.0015 inch thickness of polyvinylidene fluoride polymer. It is within the scope of the invention to use other tube constructions of various materials wherein the construction exhibits the appropriate flexibility and sealing. Tube 12 accepts guidewire 16 with such close tolerance that guidewire 16 may be inserted, removed and rotated within tube 12 but with insufficient space to allow inflation or deflation of balloon-like member 14 in a reasonable amount of time with guidewire 16 in place.
FIG. 2 illustrates the close fitting relationship of guidewire 16 within tube 12. As can be seen by comparing FIG. 2 with prior art devices shown in FIGS. 3 and 4, the overall dimension of the subject invention is much smaller.
FIG. 3 illustrates a fixed wire catheter shown generally at 22 having a single inflation tube 24 positioned around a fixed wire 26 and having annular region 28 therebetween for passage of a fluid to inflate a balloon (not shown) that would be positioned at the distal end of such an FW catheter. The term "fixed wire" means that wire 26 is permanently attached to the distal end of the FW catheter and may not be removed; removal would compromise the steerability and pushability of such an FW catheter.
FIG. 4 illustrates an over the wire catheter shown generally at 30 which provides tube 32 to accept guidewire 34 which is moveable and removable and can be extended distal to the distal end (not shown) of the catheter for steering purposes. Inflation tube 36 is also provided. The advantages of OTW catheter 30 over FW catheter 22 are that the OTW catheter is steerable, has high column strength for pushability, and allows for the exchange of guidewire 34. A major disadvantage of the OTW catheter is its large profile. As can be appreciated from FIGS. 2-4, the balloon on a tube construction of the subject invention has a much smaller profile than either OTW catheter 30 or FW catheter 22 and has all of the advantages of OTW catheter 30.
As previously mentioned, catheter 10 may be described as a balloon on a tube in that balloon-like member 14 is attached directly to tube 12. For insertion purposes, guidewire 16 is positioned within tube 12 but is removed for the purpose of inflation. The profile shown in FIG. 2 is therefore the smallest profile of an angioplasty catheter that would benefit from the use of a guidewire.
With reference to FIG. 1, guidewire 16 has a proximal end 38 and a distal end 40. Distal end 40 is shown to be generally tapered at taper 42 to increase the flexibility of guidewire 16. Distal end 40 also includes end portion 44 which engages and manipulates floppy tip wire means 46. It is understood that it is within the scope of the invention for guidewire 16 to have alternative cross-section and/or distal end portions similar to those shown at 42. These alternative guidewires may be varied in material and/or cross-section to alter the flexibility and therefore the steerability of the overall device. FIG. 1a illustrates alternative distal end 40 which is shown as a cylinder having a generally uniform cross-section which for the same material would be less flexible than taper 42.
It can be seen in FIG. 1 that floppy tip wire means 46 is a part of the means for detaching, engaging and rotating the distal end of the catheter to allow steering. Balloon-like member 14 is connected to tube 12 toward distal end 20 of tube 12. Inside balloon-like member 14 the end of tube 12, which preferably comprises a wire wound member, is elongated by stretching the coils 48 of tube 12. Coils 48 are also stripped of their sealing cover such that fluid passing through tube 12 (with guidewire 16 removed) may exit into the interior of balloon-like member 14, both axially and radially, through the spaced coils 48.
Catheter 10 further includes tubular member 50 having proximal end 52 and distal end 54. Proximal end 52 is connected to the distal end of tube 12. The distal end of balloon-like member 14 is connected to tubular member 50 at distal end 54 of tubular member 50. Floppy tip wire means 46 is positioned within tubular member 50 and includes engagement cup 56 which is slidably received within tubular member 50. The engagement cup is connected to floppy tip wire means 46 at 58. At the distal end of catheter 10 a bushing 62 of low friction material such as TeflonŽ is positioned about floppy tip wire means 46 beneath the connection of balloon-like member 14 to tubular member 50. Tubular member 50 also includes vent openings 60 to allow fluid that may be contained within tubular member 50 to escape into the interior of balloon-like member 14 as engagement cup 56 moves within tubular member 50.
Engagement cup 56 is complementary in configuration to end portion 44 of guidewire 16 such that end portion 44 engages, rotates and disengages from cup 56. When end portion 44 engages cup 56 and guidewire 16 is extended toward the distal end of catheter 10, end portion 44 moves engagement cup 56 and floppy tip wire means 46 through bushing 62. Although end portion 44 is shown to have a taper to removably engage cup 56, it is within the scope of the invention to use other complementary configurations such as a spline, a barb, a roughened interface or other means to ensure engagement/disengagement. Floppy tip 64 is preferably a wound member of platinum. A safety wire is also attached to secure floppy tip 64.
Although a bushing 62 is shown, it is within the scope of the invention to seal the floppy tip wire means with a high viscosity lubricant such as high molecular weight silica or the like. Other mechanical expedients that will allow movement yet provide sealing are also acceptable.
FIG. 5 illustrates the engagement of end portion 44 of guidewire 16 to engagement cup 56 wherein floppy tip wire means 46 is fully extended through the distal end of catheter 10. The floppy tip wire means 46 may literally be flipped around by the operator much like the bitter end of a line to access an off axis opening. The floppy tip wire means 46 should be sufficiently long to allow such throwing motion when fully extended. In the position shown in FIG. 5, balloon-like member 14 has not been inflated, and the overall stiffness of catheter 10 in the region of balloon-like member 14 is at its greatest to, for example, allow the overall structure to be pushed through a lesion. In practice, balloon-like member 14 would be further compacted onto tubular member 50. This is accomplished by folding deflated balloon-like member 14 on top of itself in overlapping fashion around the circumference of tubular member 50 to reduce the overall profile of catheter 10 in the region of balloon-like member 14. The balloon-like member 14 is not an elastomeric material but rather is a substantially crystalline polymer which is formed into shape by heating, expanding and quenching. Such a balloon-like member is relatively indistensible over a wide pressure range at 37° C. and therefore inflates to a predetermined (as manufactured) size.
FIG. 6 illustrates catheter 10 after the removal of guidewire 16 and the introduction of fluid into the interior of balloon-like member 14 through coils 48 of tube 12. In practice, engagement cup 56 would most likely be positioned near the proximal end 52 of tubular member 50 since engagement cup 56 would be prevented by the end of tube 12 from moving into lumen 12.
From the foregoing detailed description of the embodiments of this invention, it is evident that there may be a number of changes, adaptations and modifications which come within the province of those skilled in the art. However, it is intended that all such variations not departing from the spirit of the invention should be considered to be within the scope thereof as limited solely by the appended claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3402717 *||12 Aug 1965||24 Sep 1968||George O. Doherty||Endotracheal tube with valved balloon having a removable inflation stylet insert therein|
|US3726283 *||7 Oct 1971||10 Apr 1973||Kendall & Co||Body-retained catheter|
|US3837347 *||20 Apr 1972||24 Sep 1974||Electro Catheter Corp||Inflatable balloon-type pacing probe|
|US3890970 *||21 Jan 1974||24 Jun 1975||Gullen Robert L||Retention cannula or catheter and applicator|
|US4130119 *||1 Apr 1977||19 Dec 1978||Barlow Mfg. Corp.||Occlusion device|
|US4444188 *||22 Jul 1981||24 Apr 1984||Seymour Bazell||Balloon catheter|
|US4606347 *||8 Aug 1985||19 Aug 1986||Thomas J. Fogarty||Inverted balloon catheter having sealed through lumen|
|US4771778 *||6 Jan 1987||20 Sep 1988||Advanced Cardiovascular Systems, Inc.||Steerable low profile balloon dilatation catheter|
|US4793350 *||6 Jan 1987||27 Dec 1988||Advanced Cardiovascular Systems, Inc.||Liquid filled low profile dilatation catheter|
|US4813934 *||7 Aug 1987||21 Mar 1989||Target Therapeutics||Valved catheter device and method|
|US4821722 *||6 Jan 1987||18 Apr 1989||Advanced Cardiovascular Systems, Inc.||Self-venting balloon dilatation catheter and method|
|US4848344 *||13 Nov 1987||18 Jul 1989||Cook, Inc.||Balloon guide|
|US4931036 *||18 Mar 1988||5 Jun 1990||Aisin Seiki Kabushiki Kaisha||Intra-aortic balloon pump|
|US4932959 *||1 Dec 1988||12 Jun 1990||Advanced Cardiovascular Systems, Inc.||Vascular catheter with releasably secured guidewire|
|US4998923 *||23 Dec 1988||12 Mar 1991||Advanced Cardiovascular Systems, Inc.||Steerable dilatation catheter|
|US5032113 *||13 Apr 1989||16 Jul 1991||Scimed Life Systems, Inc.||Innerless catheter|
|DE3408809A1 *||10 Mar 1984||12 Sep 1985||Schubert Werner||Devices on a catheter to improve removal of conducting pathway stenoses|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US5224933 *||23 Mar 1992||6 Jul 1993||C. R. Bard, Inc.||Catheter purge device|
|US5312340 *||17 Mar 1992||17 May 1994||Scimed Life Systems, Inc.||Balloon dilatation catheter having dual sealing plugs|
|US5338295 *||9 Apr 1992||16 Aug 1994||Scimed Life Systems, Inc.||Dilatation catheter with polyimide-encased stainless steel braid proximal shaft|
|US5378238 *||8 Jun 1993||3 Jan 1995||Scimed Life Systems, Inc.||Innerless dilatation catheter with balloon stretch or manual valve|
|US5409470 *||7 May 1993||25 Apr 1995||C. R. Bard, Inc.||Dilatation catheter and guidewire with threaded tip connection|
|US5417658 *||9 Jun 1994||23 May 1995||Scimed Life Systems, Inc.||Balloon dilatation catheter having a torsionally soft component|
|US5423755 *||26 Aug 1992||13 Jun 1995||Advanced Cardiovascular Systems, Inc.||Catheter for prostatic urethral dilatation|
|US5429597 *||1 Mar 1994||4 Jul 1995||Boston Scientific Corporation||Kink resistant balloon catheter and method for use|
|US5441484 *||6 Dec 1993||15 Aug 1995||Scimed Life Systems, Inc.||Balloon dilatation catheter having a free core wire|
|US5484408 *||20 Jun 1994||16 Jan 1996||Scimed Life Systems, Inc.||Innerless catheter|
|US5490837 *||2 Mar 1994||13 Feb 1996||Scimed Life Systems, Inc.||Single operator exchange catheter having a distal catheter shaft section|
|US5522834 *||14 Nov 1994||4 Jun 1996||Applied Medical Resources Corporation||Internal mammary artery catheter and method|
|US5533987 *||22 Nov 1995||9 Jul 1996||Scimed Lifesystems, Inc.||Dilatation catheter with polymide encased stainless steel braid proximal shaft|
|US5569201 *||5 Oct 1995||29 Oct 1996||Scimed Life Systems, Inc.||Balloon catheter with distal seal|
|US5833706 *||18 May 1995||10 Nov 1998||Scimed Life Systems, Inc.||Single operator exchange perfusion catheter having a distal catheter shaft section|
|US5882336 *||28 Feb 1997||16 Mar 1999||Janacek; Jaroslav||Dilation catheter|
|US5921957 *||12 Jul 1994||13 Jul 1999||Scimed Life Systems, Inc.||Intravascular dilation catheter|
|US5947927 *||23 Mar 1998||7 Sep 1999||Scimed Life Systems, Inc.||Convertible catheter having a single proximal lumen|
|US5976107 *||6 Mar 1997||2 Nov 1999||Scimed Life Systems. Inc.||Catheter having extendable guide wire lumen|
|US5989218 *||18 Nov 1997||23 Nov 1999||Advanced Cardiovascular Systems, Inc.||Perfusion catheter with coil supported inner tubular member|
|US6090126 *||18 Jun 1997||18 Jul 2000||Scimed Life Systems, Inc.||Catheter seal|
|US6117106 *||14 Oct 1999||12 Sep 2000||Advanced Cardiovascular Systems, Inc.||Perfusion catheter with coil supported inner tubular member|
|US6146001 *||17 Dec 1998||14 Nov 2000||Patrick Alexander, Co., Inc.||Balloon luminary|
|US6648854||14 May 1999||18 Nov 2003||Scimed Life Systems, Inc.||Single lumen balloon-tipped micro catheter with reinforced shaft|
|US7189215 *||15 Aug 2003||13 Mar 2007||Medtronic Vascular, Inc.||Catheter with full-length core wire shaft for core wire interchangeability|
|US7291110 *||11 Oct 2002||6 Nov 2007||Boston Scientific Corporation||Catheter lesion diagnostics|
|US7377931 *||11 Aug 2004||27 May 2008||Medtronic Vascular, Inc||Balloon catheter with self-actuating purging valve|
|US7468051||2 Mar 2004||23 Dec 2008||Boston Scientific Scimed, Inc.||Occlusion balloon catheter with external inflation lumen|
|US7632242||9 Dec 2004||15 Dec 2009||Boston Scientific Scimed, Inc.||Catheter including a compliant balloon|
|US7641669||29 Mar 2004||5 Jan 2010||Boston Scientific Scimed, Inc.||Intravascular occlusion balloon catheter|
|US8021329||7 Dec 2009||20 Sep 2011||Boston Scientific Scimed, Inc.,||Catheter including a compliant balloon|
|US8043313||25 Oct 2011||Hotspur Technologies, Inc||Apparatus and methods for treating obstructions within body lumens|
|US8540668||15 Sep 2011||24 Sep 2013||Boston Scientific Scimed, Inc.||Catheter including a compliant balloon|
|US8926649||11 Apr 2012||6 Jan 2015||Hotspur Technologies, Inc.||Apparatus and methods for treating obstructions within body lumens|
|US8939991||8 Jun 2009||27 Jan 2015||Hotspur Technologies, Inc.||Apparatus and methods for removing obstructive material from body lumens|
|US8945160||23 Jul 2010||3 Feb 2015||Hotspur Technologies, Inc.||Apparatus and methods for treating obstructions within body lumens|
|US9101382||23 Aug 2011||11 Aug 2015||Hotspur Technologies, Inc.||Apparatus and methods for treating obstructions within body lumens|
|US9126013||26 Apr 2013||8 Sep 2015||Teleflex Medical Incorporated||Catheter with adjustable guidewire exit position|
|US20030092977 *||11 Oct 2002||15 May 2003||Sahatjian Ronald A.||Catheter Lesion diagnostics|
|US20040092867 *||15 Aug 2003||13 May 2004||Medtronic Ave Inc.||Catheter with full-length core wire shaft for core wire interchangeability|
|US20040181189 *||29 Mar 2004||16 Sep 2004||Scimed Life Systems, Inc.||Intravascular occlusion balloon catheter|
|US20050197667 *||2 Mar 2004||8 Sep 2005||Scimed Life Systems, Inc.||Occlusion balloon catheter with external inflation lumen|
|US20060036275 *||11 Aug 2004||16 Feb 2006||Bagaoisan Celso J||Balloon catheter with self-actuating purging valve|
|US20070288036 *||9 Jun 2006||13 Dec 2007||Niranjan Seshadri||Assembly for crossing a chronic total occlusion and method therefor|
|US20090105643 *||17 Dec 2008||23 Apr 2009||Boston Scientific Scimed, Inc.||Occlusion balloon catheter with external inflation lumen|
|US20100036410 *||2 Jul 2009||11 Feb 2010||Hotspur Technologies, Inc.||Apparatus and methods for treating obstructions within body lumens|
|US20110125132 *||23 Jul 2010||26 May 2011||Hotspur Technologies, Inc.||Apparatus and methods for treating obstructions within body lumens|
|EP0817657A1 *||26 Mar 1996||14 Jan 1998||Micro Interventional Systems, Inc.||Single-lumen balloon catheter and method for its intraluminal introduction|
|WO1995023626A1 *||24 Feb 1995||8 Sep 1995||Boston Scient Corp||Removable core balloon on a wire|
|WO2006062757A1 *||29 Nov 2005||15 Jun 2006||Boston Scient Scimed Inc||Catheter including a compliant balloon|
|U.S. Classification||606/194, 604/913, 604/99.01|
|Cooperative Classification||A61M2025/0079, A61M2025/1093, A61M2025/1063, A61M25/104, A61M25/09|
|5 Mar 1991||AS||Assignment|
Owner name: PROGRESSIVE ANGIOPLASTY SYSTEMS, INC., 1350 WILLOW
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:HESS, ROBERT L.;CALLISTER, JEFFREY P.;REEL/FRAME:005633/0233;SIGNING DATES FROM 19910301 TO 19910304
|7 Dec 1993||CC||Certificate of correction|
|13 Feb 1996||FPAY||Fee payment|
Year of fee payment: 4
|12 Feb 1998||AS||Assignment|
Owner name: UNITED STATES SURGICAL CORPORATION, CONNECTICUT
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PROGRESSIVE ANGIOPLASTY SYSTEMS, INC.;REEL/FRAME:008989/0545
Effective date: 19971215
|24 Feb 2000||FPAY||Fee payment|
Year of fee payment: 8
|20 Jun 2001||AS||Assignment|
|10 Mar 2004||REMI||Maintenance fee reminder mailed|
|25 Aug 2004||LAPS||Lapse for failure to pay maintenance fees|
|19 Oct 2004||FP||Expired due to failure to pay maintenance fee|
Effective date: 20040825